DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The claims filed on November 11th, 2025, have been entered. Claims 16, 19-23, and 31-33 remain pending in the Application. Claims 24-30 were previously withdrawn by the Applicant. The claim amendments overcome the previous 112(b) rejection.
Response to Arguments
Applicant's arguments filed November 11th, 2025, have been fully considered but they are not persuasive.
Applicant argues that the amendment “wherein the needle guide body is laterally movable to a next needle insertion side based on an automated sequence determined by the controller” because neither Chu et al. (Pub. No. 2020/0352672) nor Nakamura (Pub. No. 2020/0121287) disclose the needle guide assembly is manipulated by the controller and is instead manipulated manually by the hand of a medical professional (FIG. 5 of Chu et al. and FIG. 6 of Nakamura). Applicant further cites: [0107] of Nakamura that “a clinician may determine whether additional ablation is needed and, if so, where to plan for the next probe to be used;” [0109] of Nakamura that “the margin map may be used by a clinician to determine whether or not to edit a procedure plan and/or to evaluate whether the plan or procedure is optimal;” FIG. 13 and [0115] of Nakamura that “the operator defines targets;” [0118] of Nakamura that “the operator mounts the medical guidance device 105;” [0122] of Nakamura that “the operator may manually rotate the guide;” and [0127] of Nakamura that “if the position of the inserted needle-like medical tool is checked and the user satisfied with the results” in support of the assertion that in Nakamura, the sequence is not automated but rather determined by an operator and handled manually. Examiner respectfully disagrees. The claim does not require that the needle guide body is laterally moved by the controller, and only that the lateral movement is based on an automated sequence determined by the controller. [0098] of Nakamura states that the first processor 1201 (which is disclosed in [0085] as part of system 2) “may update the trajectory automatically to reduce error” and “may update the insertion point to set the center of the guidance device 105, and may calculate the insertion angle and depth thereafter.” These calculations are an automated determination of the sequence of needle insertion being performed by the controller 2, and are thereby an automated sequence that indicates where the lateral movements should be made. Since the operator moves the needle guide body in accordance with these calculations ([0099]), the reference satisfies the claim limitation by having the needle guide body moved lateral based on the automated sequence determined by the controller.
Applicant further argues that Nakamura does not disclose the lateral movement is based on at least one parameter determined by the controller, where the parameter is the relative positions between consecutive needle insertion sites because the placement of the needle guide assembly is determined by a medical professional and the computer processors simply provide interactive images ([0122]). Examiner respectfully disagrees, as that same paragraph [0122] of Nakamura states that the processors target and guide the operator to where the next needle-like medical device should be inserted based on the real-time positions of the various elements of the overall guide. Therefore, the controller’s processors are determining the lateral movement based on the relative positions of needle insertion sites, even if the decision to insert at that point and to actuate the insertion are performed by the operators.
Applicant next argues that Chu et al. as modified by Nakamura does not disclose the articulated arm comprises a plurality of sequentially arranged sections that pivot relative to each other but does not address the modification described in the Non-Final Rejection dated August 12th, 2025, except to say that the modification is not fully explained/described, is illogical, and is hindsight based. Examiner respectfully disagrees. As described in the Non-Final Rejection, the controller of Nakamura requires the apparatus 105 shown in FIG. 5B to provide relative data on positioning of the needle guide. In order to modify Chu et al. to have the apparatus 105, the needle guide body of Chu et al. would take the place of 70 of Nakamura, which would create at least two pivot points: first, at the hinge assembly 62,64 of Nakamura; and second, in the needle guide body Chu et al. at the proximal end 324 to allow for the needle guide body to open and close on the needle at the distal end. Therefore, the combined invention has a plurality of sequentially arranged sections (the two pivot points) that pivot relative to each other.
Applicant also argues that the modification by Medina (Pub. No. 2020/0113613) does not disclose the cross-section of the two separable portions tapers from a wider first end adjacent to the hinge to a narrower second end adjacent to the channel because the cross-sections of 92a and 92b are rectangular. Examiner respectfully disagrees. While 92a and 92b may appear substantially rectangular in the FIG. 4A, the claim does not require a particular shape of cross-section or a minimum amount of taper to occur, and the change in cross-section illustrated by the annotated FIG. 4A provided in the Non-Final Rejection shows that the reference satisfies the claim limitation.
Finally, Applicant argues that Nakamura does not disclose the channel formed by the two separable portions is facing and approximately parallel to the next needle insertion site because [0128] only describes the guide 150 can be decoupled and removed from the movable ring. Examiner respectfully disagrees. When the guide 150 is decoupled from the movable ring 120, the guide can be oriented such that each of the needle-like medical tools passes through the gap 170 ([0128]), which would place 170 approximately parallel to the other needle insertion sites. Since “facing” is not defined in the claims, any portion of 170 that has a surface in a direction of the other needle insertion sites can be considered facing those sites.
The rejection of claim 23 under 103 over Chu et al. (Pub. No. 2020/0352672) in view of Nakamura (Pub. No. 2020/0121287) has been withdrawn in light of Applicant’s amendment made November 11th, 2025; specifically, Chu et al. in view of Nakamura does not teach the at least two separable portions are configured to move translationally relative to each other in a rectilinear motion between the open and closed configurations.
Applicant’s arguments with respect to claim(s) 23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted that Applicant argues that the newly added claim limitations are not taught by Chu et al. and Nakamura; however, as discussed below, the newly added reference Marucci et al. (U.S. Patent No. 6,582,451).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 16, 19-22, 31, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (Pub. No. 2020/0352672) in view of Nakamura (Pub. No. 2020/0121287).
Regarding claim 16, Chu et al. discloses an automated needle guide assembly (300; [0037]; FIGs. 4A-4B) comprising:
a needle guide body (310, 320) comprising at least two separable portions (FIGs. 4A-4B: 310 and 320 can separate from each other);
wherein the needle guide body actuates between a closed configuration (FIG. 4B: 310 and 320 are closed) and an open configuration (FIG. 4A: 310 and 320 are open), wherein in the closed configuration, the at least two separable portions combine to define a channel therethrough for receiving a needle ([0037] 310 and 320 define lumen 330, which needle 150 is inserted into), and wherein in the open configuration, the at least two separable portions separate to release the received needle from the channel (FIG. 4A: 310 and 320 are open to allow 150 to be released),
wherein the channel comprises a proximal end (FIG. 4B: 330 has a proximal end) and a distal end (FIG. 4B: 330 has a distal end), and wherein the needle is configured to be received at the proximal end and inserted through the channel toward the distal end (FIG. 4B: 150 is inserted into the proximal end of 330 and goes through 330 towards the distal end of 330);
wherein an axis of the channel is aligned in use with a needle insertion site adjacent to the distal end ([0041] the distal ends of 310 and 320, which are 318 and 328, can be pivoted on or along the patient's skin to create proper orientation of the needle 150) and wherein the needle guide body is pivotable about the distal end ([0041] the distal ends of 310 and 320, which are 318 and 328, can be pivoted on or along the patient's skin to create proper orientation); and
wherein the needle guide body is laterally movable to a next needle insertion site ([0041] the distal ends of 310 and 320, which are 318 and 328, can be laterally adjusted to go between needle insertion sites).
Chu et al. does not disclose that a controller communicatively coupled to the needle guide body, where the needle guide body lateral movement is based on an automated sequence determined by the controller that minimizes movement and avoids collision between the needle guide body and previously inserted needles.
Nakamura teaches in the same field of endeavor of needle insertion guides (Abstract), and discloses a needle guide system (FIG. 6; [0081]) comprising a needle guide (105) and a controller (2) communicatively coupled to the needle guide ([0081] 2 sends instructions to, and receives feedback from, 105; FIG. 6), where the needle guide lateral movement is based on an automated sequence determined by the controller that minimizes movement and avoids collision between the needle guide and previously inserted needles ([0107-108] when multiple probes/needles are being used in medical procedures such as ablation, a sequence is carried out comprising inserting a needle, confirming the needle is in the correct position, moving the guide to the next position, and inserting the next needle; as discussed in the Response to Arguments above, the sequence is automated as disclosed in [0098] by the first processor 1201 automatically making the calculations), for the purpose of correcting errors and reducing the margin of error as the procedure is being undertaken ([0109]; FIG. 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the needle guide assembly of Chu et al. to include a controller communicatively coupled to the needle guide body, where the lateral movement of the needle guide body is based on an automated sequence determined by the controller that minimizes movement and avoids collision between the needle guide body and previously inserted needles, as taught by Nakamura, for the purpose of correcting errors and reducing the margin of error as the procedure is being undertaken when compared to manual operation ([0006] and [0109]).
Regarding claim 19, Chu et al. as modified by Nakamura further discloses the needle guide body is movable laterally to the next needle insertion site based on at least one parameter determined by the controller (Nakamura [0129] 2 plans the medical procedure, including the needle guide movement for deciding how to move from inserting a first needle to inserting the next needle; FIG. 13).
Regarding claim 20, Chu et al. as modified by Nakamura further discloses the at least one parameter comprises relative positions between consecutive needle insertion sites (Nakamura [0122] the real-time position of the needle guide on the first insertion site is compared with the target position of the next insertion site by the processors 1201 and 1201’ to determine now to move the needle guide).
Regarding claim 21, Chu et al. as modified by Nakamura further discloses an articulated arm (Chu et al.: 110; [0022]; FIG. 1; generic embodiment demonstrating the arm not shown in FIGs. 4A-4B; the modification by Nakamura also includes the articulation illustrated in FIG. 5B, where 110 of Chu et al. takes the place of 70 of Nakamura to allow for guidance by 2) mechanically connected to the needle guide body (FIG. 1: 110 is mechanically connected to 112, which is the equivalent of 310/320 in FIG. 4A) and communicatively coupled to the controller (the modification by Nakamura replaces the user manipulating the handle for the controller 2, which would send signals to 126 of Chu et al. on how to move the needle guide body), the articulated arm comprising a plurality of sequentially arranged sections that pivot relative to each other (Nakamura 205/206 and 207, and Chu et al. 110, are sequentially arranged after the modification, and pivot relative to each other as in FIG. 5B of Nakamura), for moving the needle guide body based on instructions from the controller (the modification by Fischer et al. replaces the user manipulating the handle for the controller 2, which would send signals to 126 of Chu et al. on how to move the needle guide body).
Regarding claim 22, Chu et al. as modified by Nakamura further discloses the at least two separable portions are configured to move angularly relative to each other between the open and closed configurations (Chu et al.: [0037] arms 310 and 320 can move angularly relative to each other to open and close; FIGs. 4A-4B).
Regarding claim 31, Chu et al. as modified by Nakamura further discloses the at least two separable portions comprise two separable portions connected by a hinge (Chu et al.: [0039] 310 and 320 are connected by a hinge mechanism; FIGs. 4A-4B), and wherein the hinge comprises a hinge axis parallel to the axis of the channel (Chu et al.: FIGs. 4A-4B: the axis of the hinge mechanism is parallel to the axis of 330).
Regarding claim 33, Chu et al. as modified by Nakamura further discloses the needle guide body moves to a position a fixed distance away from the next needle site (Nakamura [0129] each needle insertion site is a fixed distance from the next needle insertion site) such that the channel formed by the two separable portions is facing and approximately parallel to the next needle insertion site (Nakamura [0128] the needle channel is facing and parallel to the next target position when in the present needle insertion site).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. in view of Nakamura, and in further view of Marucci et al. (U.S. Patent No. 6,582,451).
Regarding claim 23, Chu et al. as modified by Nakamura discloses the invention as claimed in claim 23, as discussed above. The modified invention does not disclose the at least two separable portions are configured to move translationally relative to each other in a rectilinear motion between the open and closed configurations.
Marucci et al. discloses a tissue manipulator (FIG. 1A, C14:L37-62) comprising two separable portions (15a, 15b) that are configured to move translationally relative to each other in a rectilinear motion between open and closed configurations (C14:L63-C15:L11: the jaw members are pulled apart and together by movement of reciprocating rod 14, which causes them to move in parallel rather than annular) for the purpose of creating equal distribution of grip pressure along the entire jaw (C1:L38-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the jaws of Chu et al. to move translationally relative to each other in a rectilinear motion, as taught by Marucci et al., for the purpose of creating equal distribution of grip pressure along the entire jaw.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. in view of Nakamura, and in further view of Medina et al. (Pub. No. 2020/0113613).
Regarding claim 32, Chu et al. as modified by Nakamura discloses the invention as claimed in claim 31, as discussed above, and further discloses each of the two separable portions comprises a cross-section perpendicular to the axis of the channel (Chu et al. FIG. 4B). Chu et al. does not disclose the cross-section tapers from a wider first end adjacent to the hinge to a narrower second end adjacent to the channel when the needle guide body is in closed configuration.
Medina et al. teaches in the same field of endeavor of needle guide assemblies (Abstract), and discloses a needle guide (91; FIG. 4A; [0043]) comprising two separable portions (92a/94a and 92b/94b) which create a channel (58), where each of the two separable portions comprises a cross-section perpendicular to the axis of the channel (Annotated FIG. 4A below in the top view), where the cross-section tapers from a wider first end adjacent to the hinge to a narrower second end adjacent to the channel when the needle guide body is in closed configuration (Annotated FIG. 4A: the cross-section being perpendicular to the axis of the channel shown below means that the wider portion adjacent to the hinge and 96 tapers to the cylindrical narrower portion that forms the channel).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the two separable portions of Chu et al. for the two separable portions of Medina et al. because both sets of separable portions are disclosed as equivalent structures for providing a channel, and the substitution of one for the other would have resulted in the predictable result of forming a channel for guiding a needle.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771